Combination surgical drape

ABSTRACT

A surgical drape particularly useful for head surgery including a main sheet and, attached thereto, a second drape adapted to be wrapped around a body member and including adhesive means for maintaining the wrapped condition. By folding the combined drape along one edge, a cuff may be provided for safety and ease of positioning the drape.

United States Patent [191 Soto 1 FLEXIBLE PACKAGE WITH COUNTER-PRESSUREDISPENSER [76] Inventor: Ricardo Hurtado Soto, Apartado 9171 l, Bogota,Colombia 22 Filed: Jan. 23, 1975 21 Appl. No.: 543,264

[52] US. Cl 222/89; 128/214 D;

128/D1G. 24; 215/11 E; 222/81 [51] Int. Cl. A61M 25/00 [58] Field ofSearch 222/80, 81, 541, 89;

215/11 E; l28/DlG. 24, 272, 214 D [56] References Cited UNITED STATESPATENTS NOV. 16, 1976 Primary ExaminerStanley H. Tollberg AssistantExaminerDavid A. Scherbel Attorney, Agent, or FirmDawson, Tilton, Fallon& Lungmus [5 7 ABSTRACT A package includes a sealed collapsiblecontainer of puncturable film material with liquid contents. One portionof the container is formed into a pocket. The container is also providedwith structure for attachable receiving a dispenser which is adapted tobe secured to the receiving structure. The dispenser may be a cannulawith an insert or penetration conduit. When the insert conduit is placedin the pocket and forced to penetrate the innermost portion thereof, thebody of the dispenser is secured to the receiving structure of thecontainer. Pressure may be applied to the container and contents todispense the contents through the attached cannula; and this pressureforces the inner folds of the gusset into progressive sealing engagementwith the insert conduit of the cannula to prevent spillage or seepage ofthe liquid contents.

8 Claims, 8 Drawing Figures US. Patent Nov. 16, 1976 3,991,912

FLEXIBLE PACKAGE WITH COUNTER-PRESSURE DISPENSER BACKGROUND AND SUMMARYThe present invention relates to apparatus for dispensing medicaments orthe like; and more particularly, it relates to a sealed package for aliquid medica ment and a separate attachable dispenser for use with It.

The invention may be regarded as improving aspects of the devicesdisclosed in my US. Pat. Nos. 3,255,923 and 3,474,789, and in itsbroader aspects, it includes a sealed collapsible container ofpuncturable film material in which the medicament is contained. Aportion of the container is doubly folded to provide two inner foldsdefining a pocket. In one embodiment, the periphery of the container isstiffened and holds the pocket material fixed in relation to adispenser. The stiffened container material also provides a tab in frontof the gusset opening defining an aperture or providing equivalentreceiving means for a dispenser.

The dispenser may include a cannula and an insert conduit incommunication with the cannula. The insert conduit is of sufficientlength to pierce the innermost part of the pocket when the dispenser isattached to the container. The dispenser also includes a rivet-likeattaching button with a rounded head for being inserted through theaperture on the stiffened tab of the container, thereby securing thedispenser to the container after insertion of the insert conduit throughthe pocket.

The liquid contents of the container may be dispensed under gravity orunder slight hand pressure exerted on the collapsible container, as maybe required to overcome resistance or back paressure, for example, inteh case of an intramuscular injection.

One of the important features of the present invention is the means bywhich the inner folds of the gusset sealingly engage the insert conduitof the dispenser after it penetrates the innermost portion of thepocket. After piercing, the insert conduit is, of course, free totransmit the contents of the container for application or dispensing. Aspressure is applied, even the slightest pressure as would be caused bygravity acting on the contents of the container, will cause the innerfolds of the pocket to wrap around the inset conduit of the dispenser toprevent seepage through the broken portion of the pocket. As thepressure is increased on the contents, the contact area between theseinner folds and the insert conduit and the sealing force will increaseprogressively, thereby preventing seepage or loss through the puncturedlocation.

Other embodiments of the invention are disclosed for differentapplications, including variations of the means for attaching thedispenser to the container, and modifications of the dispenser fordifferent applicators.

Other features and advantages of the present invention will be apparentto persons skilled in the art from the following detailed description ofa preferred embodiment accompanied by the attached drawing whereinidentical reference numerals will refer to like parts in the variousviews.

THE DRAWING FIG. I is a front view of a package with attached dispenserconstructed according to the present invention;

FIG. 2 is a close-up cross sectional view of FIG. I showing theattachment of the dispenser and insertion into the container,

FIG. 3 is a close-up view, similar to FIG. 2, with the containerpartially cut away, but showing the dispenser prior to insertion andattachment;

FIG. 4 is a partially cut'away close-up view of the tab portion of thecontainer of FIG. 1;

FIG. 5 is a cross sectional view, similar to FIG. 2, of a firstmodification of the invention;

FIG. 6 is a partially broken-away cross sectional view, similar to FIG.2 of a second modification of the invention;

FIG. 7 is a partially broken-away exploded viewjust prior to piercing,of a third modificaton of the invention; and

FIG. 8 is a partially broken-away perspective view, with the attachingdispenser again shown in exploded relation just prior to insertion, ofafourth modification of the invention.

DETAILED DESCRIPTION Turning first to the embodiment of FIGS. 1-4,reference numeral 10 generally designates a flexible container withliquid contents 11. The container 10 may be formed by laminating twosheets of polyethylene film together having a thickness, for example, ofapproximately 5 mils. The surrounding border of the container 10 isgenerally designated I2, and it forms a stiffened, yet collapsibleperiphery, the lower end of which, designated 13 is sometimes referredto as a tab.

As best seen in FIG. 4, the tab 13 defines an aperture 14 for attachablereceiving a dispenser generally designated by reference numeral I6.Although this embodiment is designed for dispensing medicaments or thelike, the term *dispenser" is intended to have a meaning not limited tomedical applications, as will be apparent from the other embodiments.

The container 10, when viewed from the side, includes first and secondflexible side walls l7, 18. The side wall I7 is doubly folded at itsbottom portion, the two folds being designated 19 and 20 in FIG. 2, andthence laminated to the other wall 18 to form the tab 13. Thedoubly-folded wall provides a pocket having an innermost portiondesignated 2I in FIGS. 2 and 3. The pocket may be built into thecontainer, or formed by an attachment, or pre formed at the time of use.

As best seen in FIG. 3, the dispenser 16 includes an insert conduit ortube 25 having an inclined tip as at 26 to facilitate piercing of thecontainer material at the base or innermost portion of the socket. Anenlarged body portion 27 is provided with a rivet-like attaching membergenerally designated 28 and including a rounded head member 29 and aneck of reduced diameter designated 30.

At the end of the body portion 27 opposite the insert conduit 25 and influid communication with it, there is an external cannula 31 to which aflexible conduit 33 (FIGS. 1 and 2) may be attached, for example, as inthe ease of a dispenser for saline or plasma. The upper portion of thestiffened border 12 may also be provided with an aperture as at 35 inFIG. 1 for hanging the container during use.

The dispenser 16 may be made of metal or other rigid material, but itmay be made of a rigid plastic material such as high-densitypolyethylene.

The cannula 16 may be packaged separately (in a sterile enviroment formedical applications) for removal prior to use. When it is desired todispense the contents 11 of the container 10, the dispenser 16 is takenfrom its container and located approximately in the position shown inFIG. 3. It is then moved axially until the slanted tip 26 pierces theinnermost portion 21 of the pocket. The rounded head 29 of the attachingstructure 28 is then placed through the aperture 14 on the tab 13 of theflexible container to hold the dispenser in place during use.

Referring particularly to FIG. 2, when the dispenser is attached to thecontainer, and particulary when the application is one in which someresistance must be overcome or a back pressure is created (as in thecase of intramuscular injections, for example), it may be desired toinduce a pressure on the fluid contents 11 of the container 10 bycollapsing the container under hand pressure. The attachment of thecannula 16 to the container 10 resists any tendency to dislodge thedispenser, but more importantly, the flexible nature of the pocket walls19 and 20, enables them to engage the insert conduit 25 of the cannulaand seal against it, the application pressure being transmitted throughthe fluid contents to the inner surface of the container walls, asindicated diagrammatically by the arrows. Further, the greater theinternal pressure, the greater and more progressive will be the sealingarea and seal ing pressure, thereby preventing loss or spillage, notonly during insertion but also during application.

In this as in other embodiments, the limited width of the pocket inrelation to the outer diameter of the insert conduit 25 is important inthat a narrow mouth of the pocket makes it difficult to insert thedispenser, whereas a wide mouth would permit the inner fold of thepocket to extend outwardly. As an example, if the outer diameter of theinsert conduit is 14 mm., the pocket walls should be loose enough topermit easy entry but taut enough to make it difficult to insert aconduit with an outer diameter of 20 mm.

Turning now to the embodiment of FIG. 5, the flexible walls of acontainer for flowable contents are designated 117 and 118 respectively,and they are inclined toward a mouth or dispensing location 100. Apocket is formed of flexible interior walls 119 and 120.

A dispenser, generally designated 116 is heat-sealed or crirnped as at116A to the container 112 (either during manufacture or just prior touse).

In this application, the distal end of the dispenser 116 is providedwith external threads 131, and a cap 132 is secured to it. Theembodiment of FIG. 5 is particularly useful in dispensing pastes. Again,the dispenser is provided with an insert conduit 125 which pierces theinnermost portion'of the pocket formed by the flexible walls 119, 120.

Turning now to the embodiment of FIG. 6, the flexible side walls of acontainer generally designated 212 are individually designated 217 and218 respectively. The inner walls of the pocket are designated 219 and220. In this embodiment, the dispenser 216 is provided with an enlargedcollar 250 over which is received a strip or patch of adhesive orpressure-sensitive tape 251. The dispenser 216 is provided at one endwith an insert conduit 225, and at the other end with a nipple 253.

In the embodiment of FIG. 7, the flexible container is designated 312,and it has an enlarged neck 313 with first and second side borders 314and 315. Apertures 350 and 351 are provided in the borders 314 and 315 4respectively, at locations adjacent the gusset which is generallydesignated 355.

The dispenser, generally designated 316, includes an insert conduit 325and an irrigating applicator 360. The dispenser is attached to a rigidbody 361 of sheet material by means of a ring bracket 365. The body 361is provided with side tabs 370, 371, which are received in the apertures350, 351 respectively, and thence bent backward to secure the attachingdispenser and its holder to the borders of the flexible containeradjacent the mouth, after the insert conduit 325 has been inserted intothe pocket 355 and pierced the innermost end thereof to dispense thefluid contents of the container.

In the embodiment of FIG. 8, the container is similar to that shown inFIG. 7 and generally designated 312. In this embodiment, however, arigid receiving device 380 including bosses 381 is attached to thecontainer 312 adjacent its mouth, and outwardly of the pocket 355. Thecentral outer portion of the member 380 is provided with an extension383 defining a V-shaped guide surface 384 leading into a receiving mouth385.

The dispenser is generally designated 416, and it includes an insertconduit 425 and a needle 450. A central body portion 451 is providedwith a rivet-like attaching device 452, having a neck 453 which isguided, during insertion, by the guide surfaces 384 into the mouth 385,where it is secured during use. The inserted position of the insertconduit 25 is shown in dashed line, as at 425A in FIG. 8.

In all of the disclosed embodiments, it will be appreciated that thedispenser is attached or secured to the container, and that an insertconduit of the dispenser is received between the inner folds of a pocketformed in the flexible container, the insert conduit of the dispenserpiercing the innermost portion of the pocket for dispensing thecontents. Further, any back pressure during insertion or any internalpressure exerted on the contents of the container during dispensing willtransmit a sealing force to the inner folds of the pocket toprogressively wrap the inner folds of the pocket about the insertconduit in sealing, wrapping engagement to prevent loss of contentsduring insertion and use.

Having thus disclosed in detail a number of embodiments of theinvention, each modified to a different application, persons skilled inthe art will be able to alter certain of the structure which has beenillustrated or substitute equivalent elements for those disclosed whilecontinuing to practice the principle of the invention; and it is,therefore, intended that all such modifications and substitutions becovered as they are embraced within the spirit and scope of the appendedclaims.

I claim:

1. A package, comprising a sealed, collapsible container of puncturable,flexible material and defining a dispensing location, a portion of saidcontainer adjacent said dispensing location being doubly folded toprovide two inner folds defining a pocket, said folds being joined at aninnermost location; receiving means on said container adjacent saiddispensing location; dispenser means detachably securable to saidcontainer, and including an insert conduit for insertion between saidinner folds of said pocket for penetrating the innermost portion thereofto gain access to said contents of said container, and means on saiddispenser for securing said dispenser to said container at saidreceiving means adjacent said dispensing location; said receiving meanson said container providing stiffening means including a stiffened tabportion of said con tainer defining an aperture adjacent said pocket forstiffening said container adjacent said pocket to retain said foldedshape even when the contents are subjected to pressure; and meansprojecting from the body of said dispenser for extending through andcoupling with said aperture of said tab portion of said container whensaid dispenser means is inserted in assembled relation with saidcontainer; whereby back pressure during insertion of said dispensermeans and hand pressure exerted on said container after insertion willbe transmitted to the inner folds of said pocket to force the sametogether in progressive sealing engagement with said insert conduit toprevent seepage of the contents.

2. A package, comprising a sealed, collapsible container of puncturable,flexible material and defining a mouth adjacent a dispensing location, aportion of said container adjacent said dispensing location being doublyfolded to provide two inner folds defining a pocket, having a channelshape and extending across said mouth, said folds beingjoined at aninnermost location; said container including first and second aperturesadjacent the ends of said pocket; receiving means on said containeradjacent said dispensing location; and dispenser means detachablysecurable to said container, and including an insert conduit forinsertion between said inner folds of said pocket for penetrating theinnermost portion thereof to gain access to said contents of saidcontainer, and means on said dispenser means for securing said dispensermeans to said container at said receiving means adjacent said dispensinglocation; said dispenser means providing stiffening means for stiffeningsaid container adjacent said pocket to retain said folded shape evenwhen the contents are subjected to pressure and including a rigid baseportion with first and second tabs extending therefrom, said tabsregistering with the apertures on said container when said dispensermeans is assembled thereto in dispensing relation, said dispenser meansfurther comprising means for mounting said insert conduit to said rigidbase portion, whereby when said dispenser means is assembled to saidcontainer in dispensing relation, the tabs of said base portion of saiddispenser means are in register with said apertures of said containerand said tabs may be folded backwardly to releasably secure saiddispenser means to said container, said insert conduit extending throughsaid pocket and penetrating the innermost portion thereof; whereby backpressure during insertion of said dispenser means or hand pressureexerted on said container after insertion will be transmitted to theinner folds of said pocket to force the same together in progressivesealing engagement with said insert conduit to prevent seepage of thecontents.

3. The structure of claim 2 wherein said dispenser means furthercomprises an irrigation device in fluid communication with said insertconduit and extending from the other end thereof.

4. A package, comprising a sealed, collapsible container of puncturable,flexible material and defining a mouth adjacent a dispensing locationand two apertures adjacent said location, a portion of said containeradjacent said dispensing location being doubly folded to provide twoinner folds defining a pocket, said folds being a pleated portion of awall of said container extending across said mouth and joined at aninnermost location; stiffening means for stiffening said containeradjacent said folds to maintain said pocket comprising a stiff attachingmember having projections extending through the apertures of saidcontainer and including a socket with a lead-in surface; first andsecond receiving means on the periphery of said container adjacent saiddispensing location; and dispenser means detachably securable to saidcontainer, and including an insert conduit for insertion between saidinner folds of said pocket for penetrating the innermost portion thereofto gain access to said contents of said container, said insert conduitfurther including a projection adapted to snap into said socket, guidedduring insertion by lead-in surface and means on said dispenser meansfor securing said dispenser means to said container at said receivingmeans adjacent said dispensing location; whereby back pressure duringinsertion of said dispenser means or hand pressure exerted on saidcontainer after insertion will be transmitted to the inner folds of saidpocket to force the same together in progressive sealing engagement withsaid insert conduit to prevent seepage of the contents.

5. The apparatus of claim 4 wherein said dispenser means furthercomprises a needle extending from the end thereof opposite said insertconduit.

6. A package, comprising a sealed, collapsible container of puncturable,flexible material and defining a dispensing location, a portion of saidcontainer adjacent said dispensing location being doubly folded toprovide two inner folds defining a pocket, said folds being joined at aninnermost location; means for stiffening said container adjacent saidfolds to maintain said pocket; receiving means on said containeradjacent said dispensing location; and dispenser means detachablysecurable to said container, and including an insert conduit forinsertion between said inner folds of said pocket for penetrating theinnermost portion thereof to gain access to said contents of saidcontainer, and means on said dispenser for securing said dispenser tosaid container at said receiving means adjacent said dispensinglocation; said dispenser including rigid connector means releasablysecured to said dispenser means and adapted to be releasably secured tosaid container to provide said stiffening means for stiffening saidcontainer adjacent said pocket to retain said folded shape even when thecontents are subjected to pressure; whereby back pressure duringinsertion of said dispenser means or hand pressure exerted on saidcontaner after insertion will be transmitted to the inner folds of saidpocket to force the same together in progressive sealing engagement withsaid insert conduit to prevent seepage of the contents.

7. A package, comprising a sealed, collapsible container of puncturable,flexible material and defining a dispensing location, a portion of saidcontainer adjacent said dispensing location being doubly folded toprovide two inner folds defining a pocket, said folds being joined at aninnermost location; means releasably secured to said container forstiffening said container adjacent said folds to maintain said pocket;receiving means on said container adjacent said dispensing location; anddispenser means detachably securable to said container, and including aninsert conduit for insertion between said inner folds of said pocket forpenetrating ghe innermost portion thereof to gain access to saidcontents of said container, and means on said dispenser for securingsaid dispenser to said container at said receiving means adjacent saiddispensing location; said stiffening means when secured to saidcontainer stiffens said container adjacent said pocket to retain saidfolded shape even when the contents are subjected to pressure; wherebyback pressure during insertion of said dispenser means or hand pressureexerted on said container after insertion will be transmitted to theinner folds of said pocket to force the same together in progressivesealing engagement with said insert conduit to prevent seepage of thecontents.

8. A package. comprising a sealed, collapsible container of puncturable,flexible material and defining a dispensing location, a portion of saidcontainer adjacent said dispensing location being doubly folded toprovide two inner folds defining a pocket. said folds being joined at aninnermost location; means for stiffening said container adjacent saidfolds to maintain said pocket; receiving means on said containeradjacent said dispensing location; and dispenser means 8 detachablysecurable to said container, and including an insert conduit forinsertion between said inner folds of said pocket for penetrating theinnermost portion thereof to gain access to said contents of saidcontainer, and means on said dispenser for securing said dispenser tosaid container at said receiving means adjacent said dispensinglocation; said stiffening means being fixed to said dispenser means forstiffening said container adjacent said pocket to retain said foldedshape even when the contents are subjected to pressure; whereby backpressure during insertion of said dispenser means or hand pressureexerted on said container after insertion will be transmitted to theinner folds of said pocket to force the same together in progressivesealing engagement with said insert conduit to prevent seepage of thecontents.

l l I!

1. A surgical drape comprising, a base sheet of dimensions at leastsufficient to cover the area being draped and having a top surface and abottom surface, a second sheet attached to the top surface of said basesheet and having dimension substantially smaller than said base sheet,said second sheet being adapted to wrap a body member and havingadhesive means for maintaining the wrapped condition.
 2. The drape ofclaim 1 wherein said base sheet is a nonwoven fibrous material.
 3. Thedrape of claim 1 wherein said second sheet is a scrim-reinforcedcellulosic material.
 4. The drape of claim 3 wherein said second sheetis treated for liquid repellency.
 5. The drape of claim 1 wherein saidadhesive means is an adhesive tape.
 6. The drape of claim 5 furtherincluding a release strip in combination with said adhesive tape.
 7. Thedrape of claim 1 wherein said second sheet is attached adjacent an edgeof said base sheet.
 8. The drape of claim 1 folded over an edge so as toprovide a cuff for safety and ease of positioning said drape.
 9. Thedrape of claim 8 including additional adhesive means for maintainingsaid Folded condition.